Q: What do device designers need to think about for patient-friendly design?
A: I am convinced that the essence of a patient-friendly design is that it should be both intuitive and ergonomic to use. I think that the people at Apple have understood this tenet well. Taking the iPad tablet as an example: when you first take it out of its box, you are walked through set-up and initial operation in an intuitive way that is understandable even if you don’t know the first thing about a computer. This product illustrates well the concept of user-focused design.
Notwithstanding limitations imposed by regulatory requirements, I ask myself why cannot the manufacturers of inhalers treat users in the same way; tell the patient how to use it using intuitive means. To my mind, the user shouldn’t have to discover correct use by guesswork. The challenge to designers and development engineers is to work within the significant economic constraints to achieve these goals consistently from product to product.
In practice, I have observed that until recently there hadn’t been an emphasis on the patient experience, with the result that some marketed devices have been quite unintuitive to use correctly. For many years, TMI has adopted the user-friendly approach for the inhaler-based products they make. I’m therefore passionate about developing the best user interfaces for inhalers of all types as possible.
I and two colleagues at TMI published an article on this philosophy a year or so ago (Mitchell, J.P., Nagel, M. and Morton, R., “Developing Patient-Friendly Devices for Inhalation Therapy.” Respiratory Drug Delivery-Europe 2011, Eds., R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman and P.M. Young, Davis Healthcare International Publishing LLC, River Grove, Illinois, USA, 2011, 463-467).
Q: What is the role of regulatory agencies in more patient-friendly device design?
A: We already know that the FDA is going to be more involved in human factors considerations, based on a guidance document recently issued from CDRH called “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” issued in June 2011.
However, I believe that they’ve still some way to go in terms of moving all stakeholders to the point at which these considerations become as important as the traditional concerns about product efficacy and safety. Given the importance world-wide of human factors in use of drug products and related devices, I think it is also likely that the Europeans, through the EMA, will soon follow with similar guidance. This process is illustrated by advice issued to manufacturers last year by the EMA to simulate dropping an inhalation drug delivery device to see how it performs after wear-and-tear inflicted by patients.
Given these developments, it is important for all of us to understand that you can have the best inhaler in the world but if it’s not being used properly or it breaks when used, it’s a waste of both time and money. So, it doesn’t matter how many or few dollars you pay for the inhaler, it should be made to be intuitive and therefore patient-friendly in use.
